An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
Study Design: Single institution, open-label, randomized study
Study Device: Pleurx Catheter
Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic
paracentesis +/- diuretics)
Cohort B: 15 patients treated with peritoneal Pleurx catheter
Duration of Participation: Patients will be followed for one year, or until death,
whichever comes first.
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
Secondary outcomes: Overall complications, quality of life, overall survival, and symptom
control
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of Pleurx catheter or paracentesis
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
3 years
Yes
United States: Institutional Review Board
J0940
NCT01077063
February 2010
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |